Spermatozoa Morphology Selection by Thermotaxis

NCT ID: NCT04849156

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-03-09

Brief Summary

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This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.

Detailed Description

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As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques.

Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART.

The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.

Conditions

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Male Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sperm selection by thermotaxis

Selection of healthy sperm by thermotaxis procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: ≥18 and \<40 years old.
* Spermatozoa concentration \>15 x 10⁶ /mL in all sperm analysis performed in the last 24 months.
* Spermatozoa mobility \>32% in all sperm analysis performed in the last 24 months.
* Spermatozoa morphology \>4% in all sperm analysis performed in the last 24 months.
* Signed and dated informed consent

Exclusion Criteria

* Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months.
* Active smoking (during the preceding 12 months).
* More than 3 days prior to the last ejaculation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidade de Lisboa

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kadir Guleresi, Master

Role: PRINCIPAL_INVESTIGATOR

Instituto Valenciano de Infertilidade de Lisboa

Locations

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Instituto Valenciano de Infertilidade de Lisboa

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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1902-LIS-028-SR

Identifier Type: -

Identifier Source: org_study_id

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